AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml). Relieves the dryness, irritation, and discomfort that may be associated with contact lens wear.
- Company
- Abbott Medical Optics Inc (Amo)
- Recall Initiated
- July 23, 2010
- Posted
- November 2, 2010
- Terminated
- October 13, 2011
- Recall Number
- Z-0130-2011
- Quantity
- 144 units
- Firm Location
- Santa Ana, CA
Reason for Recall
The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
Distribution
International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
Lot / Code Info
Lot Numbers: AH01257.
Root Cause
Pending
Action Taken
AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.